Sat, Aug 14, 2021 page12

• TaiMed upbeat over next three years

  HIV/AIDS TREATMENT: Aside from optimism about the progress of new drugs under development, TaiMed expects a change in manufacturing partner to improve its margin

  • By Kao Shih-ching / Staff reporter
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  TaiMed Biologics Inc (中裕新藥), an HIV/AIDS drug developer, yesterday gave an upbeat outlook for the next three years, on expectations that its development of two new drugs would bear fruit and its gross margin would improve after a change in manufacturing partner, chairman James Chang (張念原) told an investors’ conference.

  TaiMed is analyzing data collected from its phase 3 clinical trial of Trogarzo (TMB-355) by intravenous push for HIV and plans to apply next month to the US Food and Drug Administration (FDA) for marketing approval, Chang said.

  The company expects to receive approval for the medication, known generically as ibalizumab-uiyk, by the end of this year, he added.

  Unlike its Trogarzo by intravenous infusion that was launched earlier, which is administered to patients after the medication is diluted with saline, Trogarzo by intravenous push can be given to patients undiluted and the administration only takes 30 seconds, compared with 15 minutes by intravenous infusion, he said.

  The new medication would be more convenient for patients and doctors alike, he said, adding that TaiMed plans to disclose the results of its phase 3 clinical trial in the next few weeks.

  TaiMed also expects to receive the US FDA’s approval for a protocol of the company’s phase 3 clinical test for Trogarzo by intramuscular injection, which would provide an even more convenient administration option for patients, Chang said.

  The company expects to receive approval within the next few days, as the regulator had reviewed the protocol and approved it in principle, he said.

  TaiMed plans to complete the phase 3 trial within nine months to one year, as the COVID-19 outbreak in the US appears to be under control and is not likely to affect its clinical test, he said, adding that the company expects to obtain marketing approval by next autumn.

  All expenses incurred in the phase 3 trial would be covered by TaiMed’s marketing and distribution partner, Theratechnologies Inc, Chang said.

  TaiMed has two other HIV drugs — TMB-365 and TMB-380 — under development and plans to conduct phase 2 clinical trials by the end of this year, he said.

  An interim analysis of a phase one trial of TMB-365 showed that 800mg of TMB-365 can last as long as 28 days, which is comparable with 2,000mg of TMB-355, and can considerably reduce a patient’s viral load, he said.

  These results indicate that TMB-365 would be a medication that last longer and patients would have to take it only once every two months, instead of every two weeks for TMB-355, which should improve their quality of life, he said.

  Chang added that TaiMed would change its main contract manufacturer from China-based WuXi Biologics Co (無錫生物製藥) to South Korea-based Samsung Biologics Laboratories.

  Although the switch cost the company about NT$400 million (US$14.4 million), the investment should pay off in a few years, as its gross margin is expected to rise from 40 percent to 70 percent with the change in partners, he said.

  Sales of Trogarzo by intravenous infusion were affected last year by the COVID-19 pandemic, as many patients could not go to hospitals to receive infusions, but the situation is expected to improve this year, Chang said.
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